NCT00967616

Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

Randomized, Active-Controlled, Open-Label Phase 2 Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.

Conditions

• Colorectal Cancer
• Neoplasms, Colorectal

Interventions

Type	Name	Description
DRUG	CS7017	CS-7017 (0.25mg tablet) Two CS-7017 tablets will be administered by mouth (PO) BID every 12 hours. FOLFIRI will be administered IV once every 2 weeks.
DRUG	irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)	FOLFIRI will be administered IV once every 2 weeks. The FOLFIRI regimen consists of: * Irinotecan, 180 mg/m\^2 IV infusion over 30 to 120 minutes * Leucovorin, 400 mg/m\^2 IV infusion to match the duration of the irinotecan infusion * 5-FU, 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46 to 48 hours continuous infusion)

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2009-08-28
• Last updated: 2020-05-04
• Results posted: 2020-05-04

Locations

18 sites across 5 countries: United States, Argentina, Brazil, Chile, Peru